Friday, July 17, 2015

HHS Seeks To Add Specific Novel Flu Lineages To Select Agents List

BSL-4 Lab Worker - Photo Credit –USAMRIID

# 10, 235

A little less than four years ago , at the 2011 ESWI Influenza Conference in Malta, Dutch researcher Ron Fouchier described the results of a groundbreaking – and later, ground shaking – experiment he’d done where he created a more `transmissible’ form of the H5N1 virus.

Halfway around the globe, and at roughly the same time, news come from Yoshihiro Kawaoka, a highly respected virologist at the University of Wisconsin-Madison School of Veterinary Medicine, that he too had created an enhanced H5N1 virus in the lab.

Suddenly, alarm bells were ringing in the biosecurity community, as concerns over both accidental releases of an `enhanced’ virus, and the wisdom of publishing details that would allow others to duplicate their experiment grew.

In the months that followed we saw a protracted, and at times rancorous, debate over the merits and safety of so-called `Gain of Function’ (GOF) research on dangerous pathogens. GOF research involves the creation of viruses and/or bacteria with enhanced virulence, transmissibility, or host range.

Adding considerable fuel to the debate, in what has truly been an annus horribilis for lab safety these past 12 months, we’ve seen a large number of high-profile lab incidents involving HPAIH5N1, Anthrax, Ebola, and smallpox involving the CDC, the FDA, and Army labs.

These, and other lab incidents, have led to calls from major journals to improve biosafety, and to even consider blocking certain types of potentially dangerous experiments unless a substantial benefit can be shown that offsets the risks.

Action

Notice Of Proposed Rulemaking And Request For Comments.

Summary

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is proposing to add certain influenza virus strains to the list of HHS select agents and toxins.

Specifically, we are proposing to add the influenza viruses that contain the hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (the influenza viruses that contain the hemagglutinin (HA) from the A/Gs/Gd/1/96 lineage), including wild-type viruses, as a non-Tier 1 select agent. We are also proposing to add any influenza viruses that contain the HA from the A/Gs/Gd/1/96 lineage that were made transmissible among mammals by respiratory droplets in a laboratory as a Tier 1 select agent. We have determined that these influenza viruses have the potential to pose a severe threat to public health and safety.

Select Agentsare a subset of biological agents and toxins that the Departments of Health and Human Services (HHS) and Agriculture (USDA) have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products.

TIER 1 Agents `are a subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety’

Under this proposed rule, viruses with Hemagglutinin (HA) from the Goose Guangdong/1/96 lineage (essentially descendents of H5N1 Clade 0), including wild-type viruses, would be considered select agents.

Laboratory modified viruses that contain the HA from the A/Gs/Gd/1/96 lineage that have enhanced respiratory transmissibility between mammals would be elevated to a Tier 1 Select Agent status.

While placement of these viruses on the Select Agents list would not prevent Gain of Function research, it would provide additional Federal oversight and require increased biosafety standards for labs doing this sort of work.

That said, I expect this will reinvigorate the heated debate over lab safety and wisdom of doing certain types of GOF research in the coming weeks.